Is your company facing challenges in process control, quality or organizational culture? Have you lost trust with regulatory bodies or customers? Partner with experts who understand your challenges and have a proven track record of turning them into opportunities.
Our process engineers, QA experts and other specialists deliver experience and transfer their knowledge. Our team includes former regulatory GMP inspectors. We implement quality in the DNA of your organization, knowing what the governments expects and inspects.
Companies worldwide rely on PCS to help them with complex challenges such as disapproved facilities, slow-moving organizations, lack of decision making and ongoing regulatory / compliance challenges.
We sidestep corporate politics to fix what's broken, ensuring swift and effective solutions.
With a lot on the line, there's no time to waste. Most of our projects are in crisis situations. We have learned to act quick, get full support in days - not weeks.
Contact our expert Jaap Koster for immediate support and guidance. Jaap has 42 years of experience in vaccine manufacturing, facility design and crisis management in the pharmaceutical industry.
Contact Jaap now
At PCS we specialize in embedding quality in the DNA of your company. We solve quality challenges, improve patient safety and help our clients become confident in their performance, business and future.
PCS provided a GMP training program for products under development for Alkermes, United States.
For Astellas and Yamanouchi, PCS conducted a number of services over the years such as GMP Document Management Consul...
To provide a qualified assessment to Baxter AG on the standards of GMP that were in place at North American Vaccine Inc.
Bharat was attempting to obtain European approval as a manufacturing site for Propopoval Injection, an intravenous oi...
PCS provided continuous on-site presence of 1 Technical Officer assisting Biological E. staff in various IQ, OQ and P...
PCS performed three GMP Audit for BioVecta, Canada. The three companies that were audited were located in China and w...
PCS provided a two-day training on FDA inspection readiness. Topics included; the regulatory background to FDA inspec...
Several GMP audits were performed for Boehringer Ingelheim, Netherlands. Additional services included the assessment...
To supply an in-house training to CAF-DCF on EU/FDA regulatory guideline updates, Annex 14 on the Manufacture of Prod...
For Cambrex, United States, PCS conducted a three day EU GMP Inspection of it's facilities. The EU cGMP inspection/mo...
Celltrion, Inc. (Celltrion), a biopharmaceutical contract manufacturer located near Seoul, Korea, required consulting...
PCS provided consultancy support to review and design a suitable logistic system for raw material and general supplie...
PCS has provided a training on Good Manufacturing Practices to Dishman Netherlands B.V.
Eurand had asked PCS to perform the second part of a mock FDA Pre Approval-type inspection on the manufacture and con...
PCS has helped FAMAR in Spain respond to a client audit with a number of GMP related CAPA's as well as training.
PCS organized in-house training for FAMAR, the Netherlands. The training focuses on the validation of production proc...
PCS performed a GMP inspection and general review on the quality systems at an Austrian supplier of Fresenius Kabi.
An inhouse GMP training was organized at GE Healthcare, spanning two days. The training included advanced GMP princip...
Gebro Pharma has asked PCS to review it's zoning concept anticipating a revision of the facilities at Gebro Pharma. G...
PCS provided support and consultancy for a project designed to implement Good Manufacturing Practices in a pilot plan...
PCS conducted a GMP audit of a support of GenIbet, Portugal. The audit was conducted in Europe and had a primary focu...
A pharmaceutical legislation training was provided to Meda Pharma of six hours in duration. The training focused on E...
PCS advised Medac on a number of GMP items for a new facility of Medac. Services included; design review, supplier qu...
PCS conducted a two-day GMP audit of a critical supplier of Medtronic. PCS was asked to ascertain compliance with cur...
To assist in the upgrade of the pharmaceutical quality systems at Meggle associated with the manufacture of inhalatio...
PCS has provided Qualified Person (QP) services to Merck Sharp & Dohme as well as GMP consultancy on internal audits,...
For NABI, PCS performed a GMP audit of the Bulk Fractionation facility, to assess premises and quality systems r...
PCS has performed over 200 supplier audits for Novartis Pharma over the past years. These audits included API's, ster...
PCS conducted an assessment of the qualification status of critical GMP equipment at Organon, the Netherlands. The eq...
PCS has lead the Corporate Quality Assurance Department of Panacea on Ad Interim basis as part of the Quality Managem...
For PharmaPack, the Netherlands PCS has organized two training sessions on GMP Risk Management and GMP Basics. Beside...
PCS performed a pre-inspection audit Protein Sciences was to receive by the U.S. FDA
For Quark Pharmaceuticals, PCS conducted a number of GMP audits. One of the audits involved a German manufacturer of...
“We believe in simplifying the complex. When your company's compliance is on the line, there's no time for corporate politics or half-measures. We dive deep into your operations to identify what's not working, and we fix or replace it. Our methods may be direct, but they are effective—and when it's time to show your commitment to quality, decisive action is a necessity.
People, Patient, Process
Our mission is to solve quality challenges, improve patient safety and help you become confident in your product, business and future.
We've partnered with organizations of all sizes, from local businesses to global giants like Novartis or Pfizer. Our international expertise ensures that no matter where you operate, we can help you make that turnaround your business needs - not only in quality but also in operations.
+31 (0)182 503 280
Houttuinlaan 4, 3447GM
Woerden, the Netherlands
Compliance issues won't resolve themselves, and the longer you wait, the greater the risk to your business. Take the first step toward restoring compliance and trust. With our unparalleled expertise and proven track record, we're the partners you need for serious, effective change.
Regulatory disapprovals, failing/slow operations, weak process control, culture and decision‑making gaps, and non‑compliant (or non‑GMP) facilities.
We mobilize quickly—typically in days, not weeks. For urgent cases, contact Jaap Koster for immediate support.
Yes. We place interim Qualified Persons, QA Directors, and related specialists under clearly defined scopes and responsibilities.
Yes. We plan and lead remediation, prepare for re‑inspection, and restore confidence with regulators and customers.
Both. We combine on‑site presence for critical activities with remote support for speed and continuity.
A blended team of process engineers, QA/validation experts, and former GMP inspectors matched to your needs.
References and anonymized case studies from over 100 pharma/biotech clients; sample deliverables upon request.
Yes. We support clients across Europe and globally.
Fixed‑fee for defined scopes or time‑and‑materials for dynamic work; we agree milestones and reporting upfront.
Download our training brochure for 2026 by clicking this link
We use cookies to improve your experience, analyze website usage, and show you relevant information. By accepting all cookies, you help us improve the website. View our privacy statement.
Cookie settings
NecessaryNoodzakelijk
Always active. Required for the website to function properly.
Statistics
Helps us improve the website through anonymous statistics.
Marketing
For third-party marketing and tracking cookies.
